Triangular Exclusion Technique in Isolated Posterior Mitral Valve Leaflet Prolapse for Mitral Valve Repair

NCT ID: NCT06778369

Last Updated: 2025-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-15

Study Completion Date

2023-06-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The goal of this clinical trial is to learn if surgical method done to repair one of the heart valve called mitral valve disease during open heart surgery

The main questions aims to answer is:

Does this method is safe and effective for long time and can be used in special cases of mitral valve surgery ? participants come to clinic to be checked clinically and radiologcally every month by the surgeon till 12 month

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

the surgical method isThe prolapsed part of the posterior leaflet of the mitral valve is inverted and excluded, toward the left ventricle but not cutted echocardiography done before participants leave hospital after sugery, after 6 month and after 12 months to confirm that this method of repair is safe and effective for participants life long

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mitral Valve Posterior Leaflet Prolapse

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

traingular exclusion technique

Triangular exclusion technique in isolated posterior mitral valve leaflet prolapse for mitral valve repair

Group Type EXPERIMENTAL

traingular exclusion technique in mitral valve repair

Intervention Type PROCEDURE

The prolapsed part of the posterior leaflet is inverted and excluded, not resected toward the left ventricle, and the margins of the prolapsed part are sutured to each other's using proline 5/0, extending from the posterior leaflet edge to the posterior annulus. Then the posterior annulus is reinforced with an annuloplasty band using a treated strip of pericardium. The determination of suitable ring size is subsequently predicated upon the assessment of inter-commissural distance surface area and the anterior leaflet, utilizing sizers that are correlated with typical mitral geometry.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

traingular exclusion technique in mitral valve repair

The prolapsed part of the posterior leaflet is inverted and excluded, not resected toward the left ventricle, and the margins of the prolapsed part are sutured to each other's using proline 5/0, extending from the posterior leaflet edge to the posterior annulus. Then the posterior annulus is reinforced with an annuloplasty band using a treated strip of pericardium. The determination of suitable ring size is subsequently predicated upon the assessment of inter-commissural distance surface area and the anterior leaflet, utilizing sizers that are correlated with typical mitral geometry.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* varying degrees of degenerative MV regurgitation, ranging from moderate to severe or severe caused by isolated prolapse of the posterior MV leaflet
* concomitant tricuspid annuloplasty

Exclusion Criteria

* with Mitral Valve stenosis or any other manifestation of mitral regurgitation pathology.
* individuals requiring surgical intervention for the aortic or pulmonary valves
Minimum Eligible Age

16 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Zagazig University

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Sameh Elsayed Saeed Elsayed

lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

sameh saeed, lecturer

Role: PRINCIPAL_INVESTIGATOR

cardiothoracic surgery department-faculty of medecine-Zagazig univeristy-Egypt

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

cardiothorathic surgery department -faculty of medecine-zagazig univeristy-Egypt

Zagazig, Sharqia Province, Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ZU-IRB # 11120-20-9-2023

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.